When FDA identifies potential safety concerns with a medical product already on the market, it can take a range of actions to communicate that information, including making a change to the product labeling. However, the impact of a safety-related labeling change on key outcomes (like drug utilization, substitute prescribing, safe use behaviors, and health outcomes) is not well understood. In order to promote the safer use of drugs and biologics and provide sufficient information to patients and healthcare providers about a product’s risk, FDA requires clearer evidence of the impact of postmarketing safety labeling changes. In support of this goal, and under a cooperative agreement with FDA, the Duke-Margolis Center for Health Policy is working with the agency to gain a better understanding of the existing literature on postmarketing safety labeling changes and develop a research agenda that can help spur the generation of additional evidence on this topic.
This expert workshop was convened by the Duke-Margolis Center in order to: 1) explore the gaps and limitations in previous research; 2) identify the research questions, types of drugs and labeling changes, and data sources, methods, and outcome measures that could be used to address these gaps; and 3) identify approaches for spurring additional studies on postmarketing safety labeling changes.
Funding for this conference was made possible in part by a cooperative agreement with the FDA’s Center for Drug Evaluation and Research. The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services nor does mention of trade names, commercial practices, or organizations imply endorsements by the U.S. Government.